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“Vivli, a Massachusetts-based nonprofit, has received $2 million from the Laura and John Arnold Foundation to build a first-of-its-kind data sharing platform for clinical trial research. The innovative platform will include a data repository, analysis tools and a dynamic search engine. It will provide transparency and access to clinical research data from around the globe, break data out of existing silos, and accelerate scientific discovery to improve human health.”

“In tumultuous times, it is easy to miss the fact that science is undergoing a quiet revolution. For several years now, concerns have been peaking in biomedicine about the reliability of published research – that the results of too many studies cannot be reproduced when the methods are repeated. Alongside growing discontent, the scientific community has answered by driving forward a raft of open science reforms. From initiatives to making research data publicly available, to ensuring that all published research can be read by the public, the aim of these reforms is simple: to make science more credible and accessible, for the benefit of other scientists and the public who fund scientific research.”

“Some of the world’s largest funders of medical research and international non-governmental organizations today agreed on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly.”

Abstract: “Science is not always plain sailing and sometimes the voyage is across an angry sea. A recent clinical trial of treatments for chronic fatigue syndrome (the PACE trial) has whipped up a storm of controversy. Patients claim the lead authors overstated the effectiveness of cognitive behavioural therapy and graded exercise therapy by lowering the thresholds they used to determine improvement. In this extraordinary case, patients discovered that the treatments tested had much lower efficacy after an information tribunal ordered the release of data from the PACE trial to a patient who had requested access using a freedom of information request.”

Abstract: “Science is not always plain sailing and sometimes the voyage is across an angry sea. A recent clinical trial of treatments for chronic fatigue syndrome (the PACE trial) has whipped up a storm of controversy. Patients claim the lead authors overstated the effectiveness of cognitive behavioural therapy and graded exercise therapy by lowering the thresholds they used to determine improvement. In this extraordinary case, patients discovered that the treatments tested had much lower efficacy after an information tribunal ordered the release of data from the PACE trial to a patient who had requested access using a freedom of information request.”

Abstract: “The International Committee of Medical Journal Editors (ICMJE) recently announced a bold step forward to require data generated by interventional clinical trials that are published in its member journals to be responsibly shared with external investigators. The movement toward a clinical research culture that supports data sharing has important implications for the design, conduct, and reporting of systematic reviews and meta-analyses. While data sharing is likely to enhance the science of evidence synthesis, facilitating the identification and inclusion of all relevant research, it will also pose key challenges, such as requiring broader search strategies and more thorough scrutiny of identified research. Furthermore, the adoption of data sharing initiatives by the clinical research community should challenge the community of researchers involved in evidence synthesis to follow suit, including the widespread adoption of systematic review registration, results reporting, and data sharing, to promote transparency and enhance the integrity of the research process.”

“Should researchers make public all the data they collect when testing drugs and medical devices on patients?

That’s been a hot question in the scientific community for years — and as debate intensified this week, an unlikely voice weighed in on the side of opening data to all: Massachusetts Senator Elizabeth Warren.”

“In recent years, tremendous progress has been made in the battle against malaria. According to the World Health Organization, the number of deaths from the disease has fallen by a staggering 60% since 2000 – the result of improved access to diagnostic testing and treatment. To be sure, there is still considerable work to be done, but the downward trend in new infections and deaths underscores the power of collaboration among governments (in malaria endemic and non-endemic countries alike), between commercial and non-profit organizations, and between academic science and medicine. Without such partnerships, advances in fighting this deadly disease would not have been possible. Alongside coordinated action on the ground, increasing openness and collaboration among scientists researching and developing a new generation of medicines and vaccines is paving the way for further progress …”

“After a month of intense conversations and negotiations, the Senate Homeland Security and Governmental Affairs Committee (HSGAC) will bring the ‘Fair Access to Science and Technology Research (FASTR) Act’ up for mark-up on Wednesday, July 29th. The language that will be considered is an amended version of FASTR, officially known as the ‘Johnson-Carper Substitute Amendment,’ which was officially filed by the HSGAC leadership late on Friday afternoon, per committee rules. There are two major changes from the original bill language to be particularly aware of. Specifically, the amendment Replaces the six month embargo period with ‘no later than 12 months, but preferably sooner’ as anticipated; and Provides a mechanism for stakeholders to petition federal agencies to ‘adjust’ the embargo period if the12 months does not serve ‘the public, industries, and the scientific community.’ We understand that these modifications were made in order accomplish a number of things: Satisfy the requirement of a number of Members of HSGAC that the language more closely track that of the OSTP Directive; Meet the preference of the major U.S. higher education associations for a maximum 12 month embargo; Ensure that, for the first time, a number of scientific societies will drop their opposition for the bill; and Ensure that any petition process an agency may enable is focused on serving the interests of the public and the scientific community …”

“Impact is multi-dimensional, the routes by which impact occur are different across disciplines and sectors, and impact changes over time. Jane Tinkler argues that if institutions like HEFCE specify a narrow set of impact metrics, more harm than good would come to universities forced to limit their understanding of how research is making a difference. But qualitative and quantitative indicators continue to be an incredible source of learning for how impact works in each of our disciplines, locations or sectors.”